The Recall Desk

Manufacturer

Oculus Optikgeraete GMBH

7 recalls in our database name Oculus Optikgeraete GMBH as the manufacturing or recalling firm.

What the numbers show

Total
7
Critical
0
Severe
0
Most recent
2023-09-06

Of the 7 recalls from Oculus Optikgeraete GMBH we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–7 of 7

  • HighFDA (Devices)·Z-2482-2023·2023-09-06

    Medical Device Recall: Oculus Pentacam AXL Wave Measurement Inaccuracy

    Oculus Pentacam AXL Wave optical devices may have insufficient anti-reflective coating, potentially causing inaccurate axial length measurements used in eye surgery planning.

    Product
    Oculus Pentacam AXL Wave, Ref 70020, CE 0123
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2484-2023·2023-09-06

    Oculus Myopia Master optical device recalled for insufficient anti-reflective coating

    Oculus Optikgeraete GMBH is recalling 173 units of the Oculus Myopia Master optical measurement device due to insufficient anti-reflective coating that may cause incorrect axial length measurements.

    Product
    Oculus Myopia Master , Ref 68100, CE 0123
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2483-2023·2023-09-06

    Oculus Pentacam AXL optical devices recalled for measurement accuracy issues

    Oculus Pentacam AXL optical devices with insufficient anti-reflective coating may produce incorrect axial length measurements, affecting 364 units distributed nationwide.

    Product
    Oculus Pentacam AXL , Ref 70100, CE 0123
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1674-2022·2022-09-07

    Pentacam HR Medical Device Software Error Impacts Surgical Planning

    A software error in the Pentacam HR eye imaging device causes inaccurate IOL calculator output for toric intraocular lens surgical planning. Nineteen systems are affected.

    Product
    Pentacam HR REF 70900. Used to image the anterior segment of the eye.
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-1673-2022·2022-09-07

    Eye imaging device software defect affects surgical planning calculations

    Pentacam eye imaging devices with certain software versions have a bug that causes inaccurate surgical planning printouts for toric intraocular lens procedures.

    Product
    Pentacam AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior segment of the eye.
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-1672-2022·2022-09-07

    Medical device software error affects toric IOL surgical planning accuracy

    A software defect in the Pentacam AXL Wave eye imaging device's IOL calculator may inaccurately reflect alignment axis and incision position for toric lens surgeries. This affects 21 systems distributed across the U.S.

    Product
    Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye.
    Category
    Medical Device
    Distribution
    37 states
  • ModerateFDA (Devices)·Z-0635-2018·2018-02-28

    Oculus Pentacam AXL Software Recall for Erroneous Quality Markings

    Oculus Optikgeraete GmbH is recalling 83 Pentacam AXL devices due to a software anomaly that may produce erroneous quality specification markings.

    Product
    OCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11, and 1.21r13. The firm name on the label is OCULUS Optikgerate GmbH, Made in Germany. The Pentacam AXL is designed to take photos of the anterior segment of the eye, which includes the cornea, pupil
    Category
    Medical Device
    Distribution
    2 states